Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index

Sponsor

Liaoning University of Traditional Chinese Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01502943

Collaborator

Ministry of Science and Technology of the People´s Republic of China (Other)

480

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the trial is to take stable angina pectoris of coronary heart disease (CHD) as examples to build a standard evaluation system for efficacy of traditional Chinese medicine (TCM).

Studies of evaluating reliability, validity and reactivates of Patients Report Outcomes of CHD and self-administrated scale of Stable Angina Pectoris
research on all indicators of CHD, and analyze their characteristics, target and function
theory of Invigorating Spleen to Remove Phlegm or replenish Qi, and activating blood and dissolving stasis as an example for clinical efficacy evaluation.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Stable Angina Pectoris	Drug: Louxiangdan Tongxin granules Drug: TCM granules placebo Drug: Chixiangshen Tongxin granules Drug: TCM granule placebo plus western basis treatment Drug: Western basis treatment	Phase 4

Detailed Description

Clinical efficacy is the basis of traditional Chinese medicine development, and scientific evaluation of TCM clinical efficacy and its effectiveness is the way to push TCM modernized and international. TCM theories of Overall concept and Differentiation for life science and diseases are hard to be generally accepted. Besides, no unified and standard methods fit to evaluate the TCM clinical efficacy. Thus, there is a need to do a deeper research of methodology, evaluative index, and evaluative criteria in order to guide the evaluation of TCM clinical efficacy.

Based on the situation above, the study aims to choose the best and characteristic evaluative index of clinical efficacy, compare the demand among practitioners, patients and care givers. After data collected, a new cluster of index among Biochemical, patients report outcomes, endpoint indicators, and TCM soft indicators could be constituted and analyzed to use in respective way according to their characteristics, target and function.

Study Design

Study Type:

Interventional

Actual Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Official Title:

Studies of Traditional Chinese Medicine Clinical Efficacy Evaluation Index With Stable Angina Pectoris of Coronary Heart Disease as an Example

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phlegm and blood stasis Syndrome G	Drug: Louxiangdan Tongxin granules TCM treatment: Decoction: Louxiangdan Tongxin granules Herbs:Danshen 10g、Chenxiang 1g、Gualou10g、Xiebai 10g、Banxia6g、Chuanxiong 6g 、Dangshen 10g、Zhiqiao 6g、Taoren 10g、Guizhi 6g Therapeutic Principle:Invigorating Spleen to Remove Phlegm and activating blood and dissolving stasis, at least 6 kinds of TCM herbs can be chosen and their dosages be adjusted according to Syndrome Differentiation. Usage:Once 100ml, twice per day after breakfast and supper. Other Names: Louxiangdan Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd Drug: Western basis treatment Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary. Other Names: Aspirin from Liaoning WanLong medicine Co.,Ltd Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation
Placebo Comparator: Phlegm and blood stasis control G	Drug: TCM granules placebo Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper. Other Names: TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd Drug: Western basis treatment Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary. Other Names: Aspirin from Liaoning WanLong medicine Co.,Ltd Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation
Experimental: Qi deficiency and blood stasis G	Drug: Chixiangshen Tongxin granules TCM treatment: Decoction: Chixiangshen Tongxin granules Herbs: Chishao 10g, Chenxiang 1g, Danggui 10g, Jupi 10g, Yanhusuo 6g, Chuanxiong 6g, Dangshen 10g, Huangqi 6g, Taoren 10g, Honghua 10g Therapeutic Principle:Invigorating Spleen to Replenish Qi and activating blood and dissolving stasis, at least 6 kinds of TCM herbs can be chosen and their dosages be adjusted according to Syndrome Differentiation. Usage:Once 100ml, twice per day after breakfast and supper. Other Names: Chixiangshen Tongxin granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd Drug: Western basis treatment Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary. Other Names: Aspirin from Liaoning WanLong medicine Co.,Ltd Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation
Placebo Comparator: Qi deficiency and blood stasis control G	Drug: TCM granule placebo plus western basis treatment Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper. Other Names: TCM placebo granules from Jiangyin Tianjiang Pharmaceutical Co., Ltd Drug: Western basis treatment Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary. Other Names: Aspirin from Liaoning WanLong medicine Co.,Ltd Atorvastatin calcium (Lipitor) from Liaoning Pharmaceutical foreign trade corporation

Outcome Measures

Primary Outcome Measures

TCM characteristics evaluative index: Traditional Chinese medicine SYndrome Scale (TCMsys) (new developed） [Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week]
New developed Quality of life evaluative index: patients report outcomes for SAP [Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week]
New developed Quality of life evaluative index: self-administrated scale of SAP [Taken at expected day 7 in the screen period, day 1 (baseline) and Change from Baseline in 2nd,4th,8th week]

Secondary Outcome Measures

Symptoms evaluative index: Measure Your Medical Outcome Profile (MYMOP), Angina incentives, symptom score scale, rate of nitroglycerin, angina classification, heart function classification [Taken at day 1 (baseline) and Change from Baseline in 2nd,4th,8th week; and all except MYMOP taken one more at expected day 7 in screen]
Biochemical index: ECG, ECG exercise test, blood lipids, blood glucose (fasting glucose), Blood, urine, liver function, renal function, coagulation, echocardiography (including heart function), coronary CT (some hospitals choose to do) [Taken at expected day 7 in the screening period (baseline) and Change from Baseline in 8th week]
Quality of life evaluative index: Seattle angina questionnaire (SAQ) [Taken at day 1 (baseline) , Change from Baseline in 2nd, 4th, 8th, 12th week]
Quality of life evaluative index: short form-12 (SF-12) [Taken at day 1 (baseline), Change from Baseline in 2nd, 4th, 8th, 12th week]
TCM characteristics evaluative index: Traditional Chinese medicine Syndrome Scale 2 (criteria) [Taken at expected day 7 in the Screening period,and Change from Baseline in 2nd,4th,8th week]
Endpoint index （Cardiovascular events, non-cardiovascular events, death, hospitalization due to coronary heart disease cases） [Taken at 2nd, 4th, 8th, 12th, 26th week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criterion：

The diagnosis standard according with stable angina coronary heart disease
The participants with any one of the below six standards are included:
history of myocardial infarction previously
PCI postoperative patients
CT showing more than 50% coronary stenosis
Coronary angiography showing more than 50% coronary stenosis
positive results of the electrocardiogram
ischemia changes in the electrocardiogram recently
The Patients with disease history more than three months, attacked in the recent one month
Standard according to the phlegm and blood stasis syndrome or Qi deficiency and blood stasis syndrome of the traditional Chinese medicine
Male: 45 years old < 75 years old
Female: 50 years old < 75 years old
Participants signed the agreement paper voluntarily.

Exclusion criterion:

Participants with Acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina), asymptomatic myocardial ischemia,ischemic cardiomyopathy,the myocardial infarction happening in the 3 months before the test
Participants with rheumatism heart disease, hyper thyroid heart disease, hypertensive heart disease, myocarditis, cardiomyopathy
Participants with Cervical disease, gallbladder cardiac syndrome, stomach and esophageal reflux, aortic dissection
Participants with acute cerebral infarction and cerebral hemorrhage
Participants with severe heart failure, lung function, liver function (AST, ALT 1.5 times normal standard), kidney function (BUN, Cr more than the normal standard), hematopoietic system and endocrine systems and serious primary disease, malignant tumor, gastrointestinal bleeding, gastric ulcer and are prone to bleed
the Participants can not complete the whole test
The serious high blood pressure and hard to control (SBP >= 180 mmHg or DBP >=110 mmHg)
Participants of acute or chronic cardiac dysfunction with heart function III-IV
Participants has been included in other clinical studies in one month;
Participants with glaucoma
Participants with Pregnancy Or Lactation ,Allergy
Participants with mental disorder, or nervous disease, or illiteracy, or bad compliance for questionnaire

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated hospital of Changchun university of TCM	Changchun	Jilin	China	110000
2	Jilin integrative Chinese and western medicine hospital	Changchun	Jilin	China	110000
3	Dalian integrative of Chinese and Western medicine hospital	Dalian	Liaoning	China	110000
4	Dandong TCM hospital	Dandong	Liaoning	China	110000
5	Fuxin TCM hospital	Fuxin	Liaoning	China	110000
6	Affiliated hospital of Liaoning university of TCM 2	Shenyang	Liaoning	China	110000
7	Affiliated hospital of Liaoning university of TCM	Shenyang	Liaoning	China	110000
8	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110000
9	Yingkou TCM hospital	Yingkou	Liaoning	China	110000
10	Affiliated hospital of Tianjin university of TCM	Tianjin	Tianjin	China	110000